MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-15 for DURO-MED GAM STERILE BURN BLANKET 60" X 90" manufactured by Briggs Medical.
[75417077]
There is no expiration date or shelf life data on the packaging for this product. Sterile burn sheet 60" x 96" crumbled when we removed and applied it to the pt. Blue dust was in the wounds. Pt was a trauma code with extensive burns. Burn cart was pulled into the room to use the supplies in the cart. The sterile burn sheet was removed from the cart and removed from its sealed package. Upon putting it on the pt the sheet disintegrated on top of the pt. It was immediately removed by staff but small blue fibers from the sheet were left on the pt's body in burned areas. Pt was estimated to have 70% burns on his body. There is no expiration date or mention of shelf life on the packaging. There is a lot number. After research there was a safety notice sent in 1997 referencing product issues after 3 years from the manufacture date. The manufacture date is part of the lot number. Also learned from research of product. All the burn sheets were from 2013 and 2012. Diagnosis or reason for use: burn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069810 |
| MDR Report Key | 6572188 |
| Date Received | 2017-05-15 |
| Date of Report | 2017-05-03 |
| Date of Event | 1996-03-28 |
| Date Added to Maude | 2017-05-17 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DURO-MED GAM STERILE BURN BLANKET |
| Generic Name | BURN BLANKET |
| Product Code | FPY |
| Date Received | 2017-05-15 |
| Model Number | 60" X 90" |
| Lot Number | JT12513 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRIGGS MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-15 |